Hospitalized ChildrenNCT05551156
The Role of Therapy Dogs in Reducing Depression, Anxiety, and Loneliness Among Hospitalized Children
A study testing Animal-assisted interaction and Conversational interaction in people with Hospitalized Children, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to test whether an animal-assisted intervention (AAI) is better than conversation with another person or treatment as usual for improving mood, anxiety, loneliness, quality of life, and indicators of health care services such as number of hospitalizations, length of hospital stay… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Hospitalized Children
- What is being tested?
- Animal-assisted interaction and Conversational interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2023to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Projected to be admitted to the hospital for the upcoming five days
- between 8-17 years of age
- speak English
- be able to provide assent (understand what the study is about and what activities are involved)
- Age 18+
- English-speaking
- Access to working phone, email, or address so that follow-up measures can be completed/sent.
Who cannot join
- Fear of or allergy to dogs
- documented contact precautions
- cognitive impairment that prevents consent/assent or completion of measures
- inability to participate in the study in the clinical judgment of their healthcare provider.
- Inability to understand documents written in English
- Fear of or allergy to dogs
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to test whether an animal-assisted intervention (AAI) is better than conversation with another person or treatment as usual for improving mood, anxiety, loneliness, quality of life, and indicators of health care services such as number of hospitalizations, length of hospital stay, and cost of services for children and adolescents.
Read the detailed description
Rationale: Loneliness is linked to a number of health threats, is considered to be as harmful as smoking 15 cigarettes a day, and is potentially more dangerous than obesity. Loneliness was considered to be at epidemic proportions prior to the COVID-19 pandemic. The resulting need for social distancing has exacerbated loneliness and other mental health concerns. Loneliness is associated with significant morbidity and mortality risks among people with Mental Illness (MI). As many as 70% of community-dwelling adults with MI endorse experiencing loneliness, which increases exponentially with the number of co-morbid psychiatric diagnoses. A growing body of evidence indicates that companion animals offer a number of health and wellbeing benefits. Interacting with a trained therapy animal as part of an animal-assisted interaction (AAI) may provide social support for patients with mental illness, thus reducing the risk of loneliness. The use of AAIs for hospitalized patients with MI as a strategy for reducing loneliness has been understudied. Scientists and practitioners need clear answers to some key questions before specific recommendations can be made.
Hypothesis/Objectives: 1. Evaluate the feasibility of a therapy dog visitation intervention (AAI) over four consecutive days on an inpatient psychiatry unit, compared to a conversational control intervention (CC), and a treatment as usual control condition (TU) in psychiatric inpatients; 2. Assess the efficacy of an AAI over four consecutive days, compared to CC, and a treatment as usual control condition (TU) in psychiatric inpatients; 3. Obtain information required to estimate sample size for a large randomized controlled trial (RCT) of a therapy dog visitation program in the population of psychiatric inpatients, combined with already funded pilot data from a sample of older adults to calculate power, determine sample size, and pursue federal funding for a large scale, multi-site, clinical trial.
Study Design and Methods: The proposed study employs a three-group RCT design to examine study implementation feasibility and effects of AAI compared to CC and TU conditions. The investigators will randomize 60 psychiatry inpatients to one of three conditions (AAI, CC, or TU) for a four-day treatment period.
Preliminary Data: Demonstrated reductions in anxiety and fear in hospitalized psychiatric patients following brief AAI provide a foundation for this work.
Expected Results: The investigators anticipate that patients will demonstrate greater improvements in the primary outcome of loneliness, and in the secondary mental health and well-being outcomes of anxiety, depression, HRQOL and mood in the therapy dog visitation program compared to the CC and TU conditions from phase 1-4 and from pre to post intervention during phase 2. The investigators anticipate that at least 50% of patients approached will consent to participation in the study. The investigators anticipate greater than 75% adherence (session completion) and less than 25% attrition (failure to attend sessions) in the AAI and CC groups. The investigators anticipate similar rates of completion in phase 3 and phase 4 assessments in the three groups, with greater failure longer after study completion. The investigators anticipate that a high proportion (at least 75%) of patients will report satisfaction with the AAI (phase 3) and that the proportion will be higher than for the CC. The investigators will explore differences in willingness to consent, instrument completion (rates of missing data), and adherence and attrition across conditions.
Potential Impact on Human-Animal Bond Research: This proposal uniquely addresses loneliness, a critical mechanism that contributes to mortality and potential morbidity among people with serious mental illness. Completing the proposed research will allow us to collect necessary pilot data to support a larger, funded, fully powered RCT to test the effectiveness of therapy dog visitation as an adjunctive treatment for people with serious mental disorders . If findings support the superior efficacy of therapy dog visitation compared to other conditions, this information can be used not only to support its use as an inpatient intervention, but to provide a foundation for studying its utility in community-based mental health contexts, such as assertive community treatment, wellness action and recovery programs, and in supportive housing.
- Conditions
- Hospitalized Children
- Being tested
- Animal-assisted interaction, Conversational interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted interactionBehavioural
Visits will occur on 3 consecutive days during your participant's inpatient hospital stay. A dog-handler team or a handler alone will visit participants with a dog for approximately 20 minutes at a convenient time for the participant. During this visit, the participant will be able to pet the dog if they wish. The handler will talk with the participants about the dog, the weather, sports, or other light topics. Participants can also suggest light topics to talk about as well.
Conversational interactionBehavioural
Visits will occur on 3 consecutive days during your participant's inpatient hospital stay. A dog-handler team or a handler alone will visit participants without a dog for approximately 20 minutes at a convenient time for the participant. During this visit, the handler will talk with the participants about the weather, sports, or other light topics. Participants can also suggest light topics to talk about as well.
| Study group | Role | What they receive |
|---|---|---|
| Animal-assisted interaction | Experimental | A dog-handler team will visit participants in their hospital room Receives: Behavioral: Animal-assisted interaction |
| Conversational interaction | Experimental | Conversational interaction with the participants and the dog-handler Receives: Behavioral: Conversational interaction |
| Treatment as usual | No intervention | Participants will received the regular services currently being received in the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression
Depressive symptomology will be measured with the 13-item Mood and Feelings Questionnaire (MFQ) which are rated on a 3 point scale. Higher scores indicate greater depression.
Measured: Baseline to end of treatment (about 5 days), 1 month after treatment
Change in Anxiety
Anxiety will be measured using the 6-item state scale of the State-Trait Anxiety Inventory for Children (STAI-C) which are rated on a 3 point scale. Higher scores indicate more anxiety.
Measured: Baseline to end of treatment (about 5 days), 1 month after treatment
Change in Mood
Mood will be measured using the Smiley Face Assessment Scale in which participants select which face fits their current mood. The scale depicts five emoticons from very sad to very happy.
Measured: Baseline to end of treatment (about 5 days), 1 month after treatment
Change in Loneliness
Child loneliness will be assessed using the 11-item version of the De Jong Gierveld Loneliness Scale for children which are answered on a 5 point scale. Higher scores indicate greater loneliness.
Measured: Baseline to end of treatment (about 5 days), 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start30 Jun 2023
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hospitalized ChildrenStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Purina Mills, Inc
- Responsible party
- Sponsor
- Investigators
- Nancy R Gee, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551156
- Sponsor's protocol ID
- HM20023539
- Status last verified
- Apr 2025
- First submitted
- 19 Sep 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.
PubMed 20668659Administration HRaS. The Loneliness Epidemic. https://www.hrsa.gov/enews/past-issues/2019/january-17/loneliness-epidemic. Published 2019. Accessed January 23, 2021.
Dell NA, Pelham M, Murphy AM. Loneliness and depressive symptoms in middle aged and older adults experiencing serious mental illness. Psychiatr Rehabil J. 2019 Jun;42(2):113-120. doi: 10.1037/prj0000347. Epub 2019 Jan 21.
PubMed 30667243Meltzer H, Bebbington P, Dennis MS, Jenkins R, McManus S, Brugha TS. Feelings of loneliness among adults with mental disorder. Soc Psychiatry Psychiatr Epidemiol. 2013 Jan;48(1):5-13. doi: 10.1007/s00127-012-0515-8. Epub 2012 May 9.
PubMed 22570258Wells DL. The state of research on human-animal relations: implications for human health. Anthrozoös. 2019;32(2):169-181.
Krause-Parello CA, Gulick, E.E., Basin, B. Loneliness, depression, and physical activity in older adults: The therapeutic role of human-animal interactions. Anthrozoös. 2019;32(2):239-254.
Barker SB, Dawson KS. The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. Psychiatr Serv. 1998 Jun;49(6):797-801. doi: 10.1176/ps.49.6.797.
PubMed 9634160Barker SB, Pandurangi AK, Best AM. Effects of animal-assisted therapy on patients' anxiety, fear, and depression before ECT. J ECT. 2003 Mar;19(1):38-44. doi: 10.1097/00124509-200303000-00008.
PubMed 12621276
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Therapy Dogs in Reducing Depression, Anxiety, and Loneliness Among Hospitalized Children
- ClinicalTrials.gov ID
- NCT05551156
- Acronym / sponsor ID
- HM20023539
- Conditions
- Hospitalized Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Purina Mills, Inc
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test whether an animal-assisted intervention (AAI) is better than conversation with another person or treatment as usual for improving mood, anxiety, loneliness, quality of life, and indicators of health care services such as number of hospitalizations, length of hospital stay, and cost of services for children and adolescents.
Detailed description
Rationale: Loneliness is linked to a number of health threats, is considered to be as harmful as smoking 15 cigarettes a day, and is potentially more dangerous than obesity. Loneliness was considered to be at epidemic proportions prior to the COVID-19 pandemic. The resulting need for social distancing has exacerbated loneliness and other mental health concerns. Loneliness is associated with significant morbidity and mortality risks among people with Mental Illness (MI). As many as 70% of community-dwelling adults with MI endorse experiencing loneliness, which increases exponentially with the number of co-morbid psychiatric diagnoses. A growing body of evidence indicates that companion animals offer a number of health and wellbeing benefits. Interacting with a trained therapy animal as part of an animal-assisted interaction (AAI) may provide social support for patients with mental illness, thus reducing the risk of loneliness. The use of AAIs for hospitalized patients with MI as a strategy for reducing loneliness has been understudied. Scientists and practitioners need clear answers to some key questions before specific recommendations can be made.
Hypothesis/Objectives: 1. Evaluate the feasibility of a therapy dog visitation intervention (AAI) over four consecutive days on an inpatient psychiatry unit, compared to a conversational control intervention (CC), and a treatment as usual control condition (TU) in psychiatric inpatients; 2. Assess the efficacy of an AAI over four consecutive days, compared to CC, and a treatment as usual control condition (TU) in psychiatric inpatients; 3. Obtain information required to estimate sample size for a large randomized controlled trial (RCT) of a therapy dog visitation program in the population of psychiatric inpatients, combined with already funded pilot data from a sample of older adults to calculate power, determine sample size, and pursue federal funding for a large scale, multi-site, clinical trial.
Study Design and Methods: The proposed study employs a three-group RCT design to examine study implementation feasibility and effects of AAI compared to CC and TU conditions. The investigators will randomize 60 psychiatry inpatients to one of three conditions (AAI, CC, or TU) for a four-day treatment period.
Preliminary Data: Demonstrated reductions in anxiety and fear in hospitalized psychiatric patients following brief AAI provide a foundation for this work.
Expected Results: The investigators anticipate that patients will demonstrate greater improvements in the primary outcome of loneliness, and in the secondary mental health and well-being outcomes of anxiety, depression, HRQOL and mood in the therapy dog visitation program compared to the CC and TU conditions from phase 1-4 and from pre to post intervention during phase 2. The investigators anticipate that at least 50% of patients approached will consent to participation in the study. The investigators anticipate greater than 75% adherence (session completion) and less than 25% attrition (failure to attend sessions) in the AAI and CC groups. The investigators anticipate similar rates of completion in phase 3 and phase 4 assessments in the three groups, with greater failure longer after study completion. The investigators anticipate that a high proportion (at least 75%) of patients will report satisfaction with the AAI (phase 3) and that the proportion will be higher than for the CC. The investigators will explore differences in willingness to consent, instrument completion (rates of missing data), and adherence and attrition across conditions.
Potential Impact on Human-Animal Bond Research: This proposal uniquely addresses loneliness, a critical mechanism that contributes to mortality and potential morbidity among people with serious mental illness. Completing the proposed research will allow us to collect necessary pilot data to support a larger, funded, fully powered RCT to test the effectiveness of therapy dog visitation as an adjunctive treatment for people with serious mental disorders . If findings support the superior efficacy of therapy dog visitation compared to other conditions, this information can be used not only to support its use as an inpatient intervention, but to provide a foundation for studying its utility in community-based mental health contexts, such as assertive community treatment, wellness action and recovery programs, and in supportive housing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Animal-assisted interaction | Experimental | Behavioral: Animal-assisted interactionA dog-handler team will visit participants in their hospital room |
| Conversational interaction | Experimental | Behavioral: Conversational interactionConversational interaction with the participants and the dog-handler |
| Treatment as usual | No intervention | –Participants will received the regular services currently being received in the hospital |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Projected to be admitted to the hospital for the upcoming five days
- between 8-17 years of age
- speak English
- be able to provide assent (understand what the study is about and what activities are involved)
- Age 18+
Key exclusion criteria (6 listed)
- Fear of or allergy to dogs
- documented contact precautions
- cognitive impairment that prevents consent/assent or completion of measures
- inability to participate in the study in the clinical judgment of their healthcare provider.
- Inability to understand documents written in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-assisted interactionVisits will occur on 3 consecutive days during your participant's inpatient hospital stay. A dog-handler team or a handler alone will visit participants with a dog for approximately 20 minutes at a convenient time for the participant. During this visit, the participant will be able to pet the dog if they wish. The handler will talk with the participants about the dog, the weather, sports, or other light topics. Participants can also suggest light topics to talk about as well. | Behavioural | Animal-assisted interaction |
| Conversational interactionVisits will occur on 3 consecutive days during your participant's inpatient hospital stay. A dog-handler team or a handler alone will visit participants without a dog for approximately 20 minutes at a convenient time for the participant. During this visit, the handler will talk with the participants about the weather, sports, or other light topics. Participants can also suggest light topics to talk about as well. | Behavioural | Conversational interaction |
Primary outcome
Change in Depression
Time frame: Baseline to end of treatment (about 5 days), 1 month after treatment
Depressive symptomology will be measured with the 13-item Mood and Feelings Questionnaire (MFQ) which are rated on a 3 point scale. Higher scores indicate greater depression.
Change in Anxiety
Time frame: Baseline to end of treatment (about 5 days), 1 month after treatment
Anxiety will be measured using the 6-item state scale of the State-Trait Anxiety Inventory for Children (STAI-C) which are rated on a 3 point scale. Higher scores indicate more anxiety.
Change in Mood
Time frame: Baseline to end of treatment (about 5 days), 1 month after treatment
Mood will be measured using the Smiley Face Assessment Scale in which participants select which face fits their current mood. The scale depicts five emoticons from very sad to very happy.
Change in Loneliness
Time frame: Baseline to end of treatment (about 5 days), 1 month after treatment
Child loneliness will be assessed using the 11-item version of the De Jong Gierveld Loneliness Scale for children which are answered on a 5 point scale. Higher scores indicate greater loneliness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 20668659Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.
- BackgroundAdministration HRaS. The Loneliness Epidemic. https://www.hrsa.gov/enews/past-issues/2019/january-17/loneliness-epidemic. Published 2019. Accessed January 23, 2021.
- Background: PubMed 30667243Dell NA, Pelham M, Murphy AM. Loneliness and depressive symptoms in middle aged and older adults experiencing serious mental illness. Psychiatr Rehabil J. 2019 Jun;42(2):113-120. doi: 10.1037/prj0000347. Epub 2019 Jan 21.
- Background: PubMed 22570258Meltzer H, Bebbington P, Dennis MS, Jenkins R, McManus S, Brugha TS. Feelings of loneliness among adults with mental disorder. Soc Psychiatry Psychiatr Epidemiol. 2013 Jan;48(1):5-13. doi: 10.1007/s00127-012-0515-8. Epub 2012 May 9.
- BackgroundWells DL. The state of research on human-animal relations: implications for human health. Anthrozoös. 2019;32(2):169-181.
- BackgroundKrause-Parello CA, Gulick, E.E., Basin, B. Loneliness, depression, and physical activity in older adults: The therapeutic role of human-animal interactions. Anthrozoös. 2019;32(2):239-254.
- Background: PubMed 9634160Barker SB, Dawson KS. The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. Psychiatr Serv. 1998 Jun;49(6):797-801. doi: 10.1176/ps.49.6.797.
- Background: PubMed 12621276Barker SB, Pandurangi AK, Best AM. Effects of animal-assisted therapy on patients' anxiety, fear, and depression before ECT. J ECT. 2003 Mar;19(1):38-44. doi: 10.1097/00124509-200303000-00008.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy R Gee, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted interaction and Conversational interaction in people with Hospitalized Children, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression (time frame: Baseline to end of treatment (about 5 days), 1 month after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05551156, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.